Table 3. Procedure and device related adverse events.

*One subject accounts for two different Reveal XT procedure related events. Neither was deemed serious by CEC or site.

Combined results		Reveal XT(N=122)				Reveal LINQ(N=272 + 1 attempt)
		Total	Serious per CEC		Serious per investigator	Total	Serious per CEC	Serious per investigator
Device and/or procedure related		11 (10*, 8.2%)	7 (5.7%)		2 (1.6%)	9 (3.3%)	6 (2.2%)	4 (1.5%)
Procedure related		6 (5*, 4.1%)	3 (2.5%)		1 (0.8%)	5 (1.8%)	4 (1.5%)	3 (1.1%)
Device related		7 (5.7%)	6 (4.9%)		1 (0.8%)	7 (2.6%)	5 (1.8%)	3 (1.1%)
Individual results
Device dislocation/ device site erosion	Device and/or procedure related	0	0	0		4 (1.5%)	4 (1.5%)	3 (1.1%)
	Procedure related	0	0	0		3 (1.1%)	3 (1.1%)	2 (0.7%)
	Device related	0	0	0		4 (1.5%)	4 (1.5%)	3 (1.1%)
Impaired healing (including pruritus or erythema)	Device and/or procedure related	2 (1.6%)	0	0		2 (0.7%)	0	0
	Procedure related	2 (1.6%)	0	0		1 (0.4%)	0	0
	Device related	0	0	0		1 (0.4%)	0	0
Insertion site infection	Device and/or procedure related	2 (1.6%)	2 (1.6%)	1 (0.8%)		0	0	0
	Procedure related	2 (1.6%)	2 (1.6%)	1 (0.8%)		0	0	0
	Device related	1 (0.8%)	1 (0.8%)	0		0	0	0
Insertion site pain / irritation	Device and/or procedure related	6 (4.9%)	4 (3.3%)	0		1 (0.4%)	0	0
	Procedure related	2 (1.6%)	1 (0.8%)	0		0	0	0
	Device related	5 (4.1%)	4 (3.3%)	0		1 (0.4%)	0	0
Oversensing	Device and/or procedure related	0	0	0		1 (0.4%)	1 (0.4%)	0
	Procedure related	0	0	0		0	0	0
	Device related	0	0	0		1 (0.4%)	1 (0.4%)	0
Shock/ dyspnea	Device and/or procedure related	0	0	0		1 (0.4%)	1 (0.4%)	1 (0.4%)
	Procedure related	0	0	0		1 (0.4%)	1 (0.4%)	1 (0.4%)
	Device related	0	0	0		0	0	0
Discomfort	Device and/or procedure related	1 (0.8%)	1 (0.8%)	1 (0.8%)		0	0	0
	Procedure related	0	0	0		0	0	0
	Device related	1 (0.8%)	1 (0.8%)	1 (0.8%)		0	0	0